Import Alert 89-07
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 89-07
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination Of Gynecological Devices Manufactured By Leiban International"
Reason for Alert:
The labeling on the device lacks the information specified in 21 CFR 801.109. Therefore, the article is not exempt from the requirement in Section 502(f)(1) that it labeling bear adequate directions for use.
Because of the unique autoexpandable feature of the speculum and the lack of specific and detailed instructions, the labeling, as provided, is inadequate. The device is unusual and, as such, the method and idiosyncrasies of its use will not be completely obvious to the clinician. Detailed instructions and caution statements are necessary to eliminate the potential hazard to health. CDRH has informed the law firm representing the manufacturer that the devices will be denied entry into the United States.
Because of the unique autoexpandable feature of the speculum and the lack of specific and detailed instructions, the labeling, as provided, is inadequate. The device is unusual and, as such, the method and idiosyncrasies of its use will not be completely obvious to the clinician. Detailed instructions and caution statements are necessary to eliminate the potential hazard to health. CDRH has informed the law firm representing the manufacturer that the devices will be denied entry into the United States.
Guidance:
Districts may detain, without physical examination, the devices from the firm identified in the attachmnet for this alert.
Product Description:
Autoexpandable and Discardable Speculum for Gynecological Use Models: Small #2, Medium #3, Large
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3), in that it appears that its labeling does not bear adequate directions for use [Misbranding, Section 502(f)(1)]."
OASIS charge code - DIRECTIONS
OASIS charge code - DIRECTIONS
Countries
ARGENTINA
(85 H - - --) Portion of device code
ARGENTINA
Lebian International S R L
Date Published : 09/16/2009
La Pax 1071 , Rosario, ARGENTINA
85 H - - -- Portion of device code
Date Published: 09/16/2009
Desc:Small #2; Medium #3; Large #4
Notes:Autoexpandable and Discardable Speculum for Gynecological Use Models
Notes:Autoexpandable and Discardable Speculum for Gynecological Use Models
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